745797
Last Update Posted: 2017-03-06
Recruiting has ended
All Genders accepted | 18 Years-75 Years |
5 Estimated Participants | No Expanded Access |
Interventional Study | Does not accept healthy volunteers |
Prophylactic Cranial Irradiation (PCI) Versus no PCI in Non Small Cell Lung Cancer After a Response to Chemotherapy
- Patients with confirmed advanced NSCLC and any response to 3-6 cycles of chemotherapy, were randomized to receive PCI (30 Gy/10fr) or no PCI.
- The primary endpoint was the cumulative incidence of symptomatic brain metastases (BM) .
- The study was sized to detect a hazard ratio of 0.37 with 80% power and 2-sided 5% significance (60 events, 206 patients).
- Prophylactic cranial irradiation (PCI) significantly reduces the risk of brain metastases (BM) and improves survival in patients with extensive disease small cell lung cancer after a response to chemotherapy .
- PCI has also demonstrated to reduce or delay the incidence of CNS failure in non small cell lung cancer patients after primary therapy.
- But its impact on overall and disease free survival is uncertain.
Eligibility
Relevant conditions:
Brain Metastases
If you aren't sure if you meet the criteria above speak to your healthcare professional. Criteria may be updated but not reflected here, do not hesitate to contact the study if you think are close to fitting criteria.
Inclusion criteria
Exclusion criteria
locations
Data sourced from ClinicalTrials.gov